a Pharmacy Department, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón , Madrid , Spain.
Expert Opin Drug Saf. 2019 Sep;18(9):861-868. doi: 10.1080/14740338.2019.1641197. Epub 2019 Jul 15.
: Although the safety profile of oral antineoplastic agents (OAAs) is better than that of classic chemotherapy, the rate of severe adverse events (AEs) is high. The objective was to assess the reasons for adjustments to treatment with OAAs during the first 100 days of treatment. : The authors performed a prospective observational study of cancer outpatients who initiated OAAs between November 2015 and October 2017. Dose reductions and treatment interruptions were closely followed-up during the first 100 days after the beginning of treatment with an OAA. The authors described the different safety profile of different OAA classes. : The authors included 443 patients (31 different OAA assessed), of whom 53.0% required their OAA to be adjusted during the first 100 days of treatment. A total of 151 patients required dose reductions and/or interruptions of OAAs owing to AEs. The authors identified 203 AEs in these patients. Treatment with sorafenib, lower ECOG performance status, and first-line treatment were associated with a higher proportion of treatment adjustments due to AEs. : These results in clinical practice could be a first approach to help healthcare professionals to design patient monitoring programs by identifying priority patients and drugs, and remarks the importance of pharmacovigilance in OAAs.
尽管口服抗肿瘤药物 (OAAs) 的安全性优于经典化疗，但严重不良事件 (AE) 的发生率仍然较高。本研究旨在评估在治疗开始后的 100 天内，OAAs 治疗调整的原因。
作者对 2015 年 11 月至 2017 年 10 月期间开始使用 OAAs 的癌症门诊患者进行了前瞻性观察研究。在开始使用 OAAs 后的 100 天内，密切监测剂量减少和治疗中断情况。作者描述了不同 OAAs 类别之间不同的安全性特征。
作者共纳入 443 例患者（评估了 31 种不同的 OAAs），其中 53.0%的患者在治疗的前 100 天需要调整 OAAs。共有 151 例患者因 AE 而需要减少 OAAs 的剂量和/或中断治疗。这些患者共发生 203 例 AE。索拉非尼治疗、较低的 ECOG 表现状态和一线治疗与因 AE 而调整治疗的比例更高相关。
这些临床实践中的结果可能是帮助医疗保健专业人员通过识别优先患者和药物来设计患者监测计划的初步方法，并强调了 OAAs 药物警戒的重要性。
